August 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 16 new animal drug applications (NADAs) and 1 abbreviated NADA (ANADA) because they are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

This proposed rule would implement section 1001(d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) which establishes new reporting and auditing requirements for State Disproportionate Share Hospital payments.

This document completes NHTSA's consideration of its responsibilities to help implement the obligations of the United States under the North American Free Trade Agreement. The agency had proposed regulations to permit retroactive certification of foreign domiciled vehicles that, while built in compliance with U.S. standards applicable at the time of manufacture, had not been labelled as such. At the same time, the Federal Motor Carrier Safety Administration had proposed to require all commercial motor vehicles operating in the U.S. to have labels certifying compliance with the Federal motor vehicle safety standards (FMVSS). After reviewing the comments on the NHTSA and FMCSA proposals, the Department has decided on a more effective and less cumbersome approach to ensuring that commercial motor vehicles were built to the FMVSS (or the very similar Canadian motor vehicle safety standards) and operate safely in the United States. FMCSA requires Mexican-domiciled carriers applying to operate in the United States to certify in their applications that their vehicles were manufactured or retrofitted in compliance with the FMVSSs applicable at the time they were built, and will confirm that certification during the pre-authority safety audit and subsequent inspections. In addition, enforcement through the Federal Motor Carrier Safety Regulations focuses on real world, operational safety and incorporates the various FMVSS applicable through the useful life of the vehicle. FMCSA will not require vehicles to have labels certifying their compliance with the standards in effect when they were built, and NHTSA is not proceeding with a retroactive certification approach or the related proposal for a new recordkeeping and retention rule. We have also decided against placing a definition of the term ``import'' in the Code of Federal Regulations. After considering the comments, we have concluded that creating a new regulation to define the term serves no regulatory function and is unnecessary for the promotion of motor vehicle safety.

The Federal Grain Inspection Service (FGIS), of the Grain Inspection, Packers and Stockyards Administration (GIPSA), is amending the regulation regarding fees assessed to delegated States and designated official agencies, hereafter known as official agencies, authorized by GIPSA to provide official inspection and weighing services to the U.S. grain industry. The fee adjustment is necessary to collect sufficient revenue to cover the current and future cost of supervising the performance of the official agencies. Current supervision fees are charged to official agencies on a unit basis and represent an average rate of approximately 0.8 cent per metric ton of grain inspected or weighed by the official agencies. The final supervision fee increases the rate to a 1.1 cents per metric ton charge. Official agencies include the cost of GIPSA's supervision fee as part of the fee they charge their customers for grain services. The current average cost for services provided by official agencies is 21 cents per metric ton. Increasing the supervision fee by approximately 0.3 cent per metric ton will minimally increase the total cost of inspection and weighing services to the grain industry.

This document contains proposed regulations providing guidance on employer comparable contributions to Health Savings Accounts (HSAs) under section 4980G. In general, these proposed regulations would affect employers that contribute to employees' HSAs.

EPA is revising the format of part 52 of Title 40 of the Code of Federal Regulations (40 CFR part 52) for materials submitted by Chattanooga, Tennessee that are incorporated by reference (IBR) into the State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by the local agency and approved by EPA. This format revision will affect the ``Identification of Plan'' sections of 40 CFR part 52, by adding a table for the Chattanooga portion of the Tennessee SIP. This revision will also affect the format of the SIP materials that will be available for public inspection at the Office of the Federal Register (OFR), the Air and Radiation Docket and Information Center, and the Regional Office.

The FAA is adopting a new airworthiness directive (AD) for Pratt & Whitney (PW) JT8D-1, -1A, -1B, -7, -7A, -7B, -9, -9A, -11, -15, -15A, -17, -17A, -17R, -17AR, -209, -217, -217A, -217C, and -219 turbofan engines. This AD requires removing affected rotating parts overhauled by a certain repair vendor, and inspecting the parts as applicable. This AD results from reports that certain JT8D critical life-limited rotating parts have been returned to service with cracks, corrosion pitting, or dimensions outside of manual limits. We are issuing this AD to prevent failure of critical life-limited rotating engine parts which could result in an uncontained engine failure and damage to the airplane.

The FAA is adopting a new airworthiness directive (AD) for certain Airbus Model A330-200, A330-300, A340-200, and A340-300 series airplanes; and Model A340-541 and -642 airplanes. This AD requires repetitively resetting the display units (DUs) for the electronic instrument system (EIS) either by switching them off and back on again or by performing a complete electrical shutdown of the airplane. This AD results from an incident in which all of the DUs for the EIS went blank simultaneously during flight. We are issuing this AD to prevent automatic reset of the DUs for the EIS during flight and consequent loss of data from the DUs, which could reduce the ability of the flightcrew to control the airplane during adverse flight conditions.

The FAA is withdrawing a previously published Advance Notice of Proposed Rulemaking that sought public comment on issues about the use of child restraint systems (CRSs) in aircraft. Specifically, we sought crash performance and ease-of-use information about existing and new automotive CRSs, when used in aircraft. We also sought information about the development of any new or improved CRSs designed exclusively for aircraft use. We are withdrawing the document to pursue other options that will mitigate the risk of child injuries and fatalities in aircraft.

The Department of Labor (DOL) is amending two regulations to allow for full implementation of the Wage Determinations OnLine (WDOL) Internet Web site (https://www.wdol.gov) as the source for federal contracting agencies to use when obtaining wage determinations issued by the DOL for service contracts subject to the McNamara-O'Hara Service Contract Act (SCA) and for construction contracts subject to the Davis- Bacon Act and Related Acts (DBRA).

The FAA is superseding an existing airworthiness directive (AD), which applies to all Airbus Model A300 B2 and B4 series airplanes; Model A300-600 series airplanes; and Model A310-200 and -300 series airplanes. That AD currently requires, among other actions, repetitive tests to detect desynchronization of the rudder servo actuators, and adjustment or replacement of the spring rods of the rudder servo actuators, if necessary. This new AD requires new repetitive tests/inspections/analyses of the rudder servo actuators, and related investigative/corrective actions if necessary. Accomplishment of the new actions ends the existing repetitive requirements. This AD is prompted by new reports of desynchronization of the rudder servo actuators. We are issuing this AD to prevent desynchronization of one of the three rudder servo actuators, which, if combined with an engine failure, could result in the loss of the related hydraulic system and could cause the loss of one of the two synchronized actuators. This condition could create additional fatigue loading and possible cracking on the attachment fittings and could result in the inability of the remaining synchronized actuator to maintain the commanded rudder deflection, which could result in reduced controllability of the airplane.

This document corrects technical errors that appeared in the proposed rule published in the Federal Register on July 25, 2005 entitled ``Medicare Program; Proposed Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates; Proposed Rule.''

The EPA is approving revisions to the South Carolina and Georgia State Implementation Plans (SIPs), submitted by the South Carolina Department of Health and Environmental Control (SC DHEC) and the Georgia Environmental Protection Division (EPD), respectively, for the Early Action Compact (EAC) areas in South Carolina and Georgia. The proposed SIP revisions were submitted on December 29, 2004, by South Carolina and December 31, 2004, by Georgia. There are ten EAC areas in South Carolina and Georgia covered by this final action: the Appalachian, Catawba, Pee Dee, Waccamaw, Santee Lynches, Berkeley- Charleston-Dorchester, Low Country, Lower Savannah, Central Midlands, and Upper Savannah EAC Areas. Only the Lower Savannah EAC Area has counties in both South Carolina and Georgia. For the purposes of this document, however, all of the above listed EAC areas will be collectively referred to as the ``South Carolina and Georgia EAC Areas.'' The SIP revisions meet the requirements for the South Carolina and Georgia EAC Areas to attain and maintain the 8-hour ozone national ambient air quality standard (the 8-hour ozone standard) as described in the EAC Protocol and related regulations. EPA is also now approving the photochemical modeling used by South Carolina and Georgia to support the attainment and maintenance demonstrations of the 8-hour ozone standard in the South Carolina and Georgia EAC Areas. The revisions being approved today further incorporate regulatory control measures into the South Carolina SIP, including two Statewide regulations pertaining to control of nitrogen oxide (NOX) emissions and open burning. In addition, this final action also corrects inadvertent errors in the May 26, 2005, proposal document relating to these SIP revisions (70 FR 30396). In today's final action, EPA is not finalizing its proposed rulemaking to defer the effective date of the nonattainment designations for EAC areas. In a separate action, published on June 8, 2005, EPA proposed to defer the effective date of the nonattainment deferred designation for EAC areas until December 31, 2006 (69 FR 23858). EPA final action on the deferral is expected to be published before September 30, 2005.

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations for Fitness for Duty (FFD) programs to update the rule and enhance consistency with advances in other relevant Federal rules and guidelines, including the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines), and other Federal drug and alcohol testing programs that impose similar requirements on NRC licensees. The proposed amendments would require nuclear power plant licensees to strengthen the effectiveness of their FFD programs in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue; and ensure consistency with the NRC's access authorization requirements for nuclear power plants. The proposed rule would ensure that individuals who are subject to these regulations are trustworthy and reliable, as demonstrated by avoiding substance abuse; are not under the influence of drugs or alcohol while performing their duties; and are not mentally or physically impaired from any other cause, that would in any way adversely affect their ability to perform their duties safely and competently. This proposed rule would also grant, in part, a petition for rulemaking (PRM-26-1) submitted by Virginia Electric and Power Company (now Dominion Virginia Power) on December 30, 1993, by relaxing several required FFD program audit frequencies, and would partially grant a petition for rulemaking (PRM-26-2) submitted by Barry Quigley on December 28, 1999.

On December 2, 2004, the proposed List of Fisheries (LOF) for 2005 under the Marine Mammal Protection Act (MMPA) was published in the Federal Register. NMFS subsequently prepared a draft Environmental Assessment (EA) on the process for classifying U.S. commercial fisheries on the LOF. NMFS is reopening the comment period on the proposed 2005 LOF for an additional 60 days to allow the public to concurrently review and comment on both the draft EA and proposed 2005 LOF.

This action establishes a Class E airspace area at Marana Regional Airport, AZ. The establishment of an Area Navigation (RNAV) Global Positioning System (GPS) Instrument Approach Procedures (IAP) RNAV (GPS) Runway (RWY) 3, 12, 21 and 30 IAP and a Nondirectional Radio Beacon (NDB) IAP to RWY 12 at Marana Regional Airport, Tucson, AZ has made this action necessary. Additional controlled airspace extending upward from 700 feet or more above the surface of the earth is needed to contain aircraft executing these RNAV (GPS) and NDB approach procedures. The intended effect of this action is to provide adequate controlled airspace for Instrument Flight Rules operations at Marana Regional Airport, Tucson, AZ.

This action establishes the Class E airspace area at Dona Ana County, Santa Teresa, NM (K5T6) to provide adequate controlled airspace for the area navigation (RNAV) global positioning system (GPS) standard instrument approach procedure (SIAP).

The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used in Molecular Diagnostic Testing).'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.

This proposed rule revises regulations governing the inspection and certification for fresh fruits, vegetables and other products by increasing by approximately 15 percent certain fees charged for the inspection of these products at destination markets. These revisions are necessary in order to recover, as nearly as practicable, the costs of performing inspection services at destination markets.

MMS is changing some existing fees and implementing several new fees to offset MMS's costs of performing certain services relating to its minerals programs.

This document contains proposed regulations under sections 162(k) and 404(k) of the Internal Revenue Code (Code) relating to employee stock ownership plans (ESOPs). The regulations provide guidance concerning which corporation is entitled to the deduction for applicable dividends under section 404(k). These regulations also clarify that a payment in redemption of employer securities held by an ESOP is not deductible. These regulations will affect administrators of, employers maintaining, participants in, and beneficiaries of ESOPs. In addition, they will affect corporations that make distributions in redemption of stock held in an ESOP.

On April 12, 2003, the EPA issued national emission standards for hazardous air pollutants (NESHAP) for reinforced plastics composites production, which were issued under section 112 of the Clean Air Act (CAA). This action will amend the final rule to revise compliance options for open molding, correct errors, and add clarifications to sections of the rule that were not clear. In the Rules and Regulations section of this Federal Register, we are taking direct final action on the proposed amendments because we view the amendments as noncontroversial and anticipate no adverse comments. We have explained our reasons for the amendments in the direct final rule. If we receive no adverse comments, we will take no further action on the proposed amendments. If we receive adverse comments, we will withdraw only those provisions on which we received adverse comments. We will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn. If part or all of the direct final rule in the Rules and Regulations section of today's Federal Register is withdrawn, all comments pertaining to those provisions will be addressed in a subsequent final rule based on the proposed amendments. We will not institute a second comment period on the subsequent final action. Any parties interested in commenting must do so at this time.

This document contains final regulations under section 951(a) of the Internal Revenue Code (Code) that provide guidance for determining a United States shareholder's pro rata share of a controlled foreign corporation's (CFC's) subpart F income, previously excluded subpart F income withdrawn from investment in less developed countries, and previously excluded subpart F income withdrawn from foreign base company shipping operations.

The Food and Drug Administration (FDA) is amending its combination product regulations to define ``mode of action'' (MOA) and ``primary mode of action'' (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.

NMFS is prohibiting directed fishing for species that comprise the shallow-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the third seasonal apportionment of the 2005 Pacific halibut bycatch allowance specified for the shallow-water species fishery in the GOA has been reached.